Caries,Dental Clinical Trial
Official title:
Clinical Performances of 3-different Tooth-colored Restorative Materials in Class-II Cavities
Verified date | January 2024 |
Source | Hacettepe University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The goal of this clinical trial comparatively investigate the clinical performances of 3 different tooth-colored restorative materials in the treatment of Class II cavities after 6 months and one year.
Status | Active, not recruiting |
Enrollment | 47 |
Est. completion date | March 20, 2024 |
Est. primary completion date | June 15, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: - Healthy individuals who do not have any systemic disease that prevents restorative treatment - Individuals between the ages of 18-65 - Brushing your teeth twice a day - Having at least 20 teeth in occlusion and at least 3 approximal lesions with antagonist teeth in the opposite arch - Volunteer individuals who agree to participate in the research and sign the informed consent form and who have undergone initial periodontal treatment will be included in the study. Exclusion Criteria: - Pregnant or breastfeeding women - Individuals with advanced periodontal disease - Individuals using removable partial dentures - Individuals with bruxism - Individuals with malocclusion - Patients with known allergies to resin-based restorative materials and bonding agents - Patients with a history of allergy to local anesthesia - Endodontic treatment, teeth that need pulp capping or endodontic treatment is available |
Country | Name | City | State |
---|---|---|---|
Turkey | Hacettepe University | Ankara |
Lead Sponsor | Collaborator |
---|---|
Hacettepe University |
Turkey,
Bektas Donmez S, Uysal S, Dolgun A, Turgut MD. Clinical performance of aesthetic restorative materials in primary teeth according to the FDI criteria. Eur J Paediatr Dent. 2016 Sep;17(3):202-212. — View Citation
Gurgan S, Kutuk ZB, Yalcin Cakir F, Ergin E. A randomized controlled 10 years follow up of a glass ionomer restorative material in class I and class II cavities. J Dent. 2020 Mar;94:103175. doi: 10.1016/j.jdent.2019.07.013. Epub 2019 Jul 25. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Surface gloss/lustre and roughness | Observers evaluated the restorations was performed using FDI criteria regarding surface gloss/lustre and roughness. Surface gloss/lustre and roughness was evaluated by 2 independent clinicians. Visual inspection with a mirror was performed.Scores; 1: Comparable to enamel 2: Slightly dull, not noticeable from speaking distance 3: Dull surface but acceptable if covered with film of saliva 4: Rough surface, cannot be masked by saliva film, simple polishing is not sufficient 5: Quite rough, unacceptable plaque retentive surface | From Baseline to 12 Month | |
Primary | Surface and marginal staining | Observers evaluated the restorations was performed using FDI criteria regarding surface and marginal staining. Surface and marginal staining was evaluated by 2 independent clinicians. Visual inspection with a mirror was performed. Scores; 1: No marginal or surface staining 2: . Minor staining, easily removable 3: Moderate staining not noticeable from a speaking distance, also present on other teeth. Not aesthetically unacceptable 4: Surface staining recognizable from speaking distance. Or severe localized marginal staining not removable by polishing 5: Severe surface staining or unacceptable. Generalized and profound marginal discoloration. | From Baseline to 12 Month | |
Primary | Colour match/stability and translucency | Observers evaluated the restorations was performed using FDI criteria regarding colour match/stability and translucency. Colour match/stability and translucency was evaluated by 2 independent clinicians. Visual inspection with a mirror was performed. Scores; 1: Colour and translucency of the restoration have a clinically excellent match with the surrounding enamel 2: Minor deviations in shade between tooth and restoration are apparent 3: Clear deviation but acceptable. Does not affect aesthetics 4: Colour and/ or translucency are clinically unsatisfactory, recognisable from speaking distance 5: Colour match and/or translucency are clinically unsatisfactory | From Baseline to 12 Month | |
Primary | Anatomic form | Observers evaluated the restorations was performed using FDI criteria regarding anatomic form. Anatomic form was evaluated by 2 independent clinicians. Visual inspection with a mirror was performed. Scores; 1: Form is ideal 2: Form deviates slightly from the remainder of the tooth 3: Form differs but is not aesthetically displeasing 4: Anatomic form is altered, the aesthetic result is unacceptable 5: Anatomic form is unsatisfactory and/or lost | From Baseline to 12 Month | |
Primary | Fracture of restorative material and retention | Observers evaluated the restorations was performed using FDI criteria regarding fracture of restorative material and retention. Fracture of restorative material and retention was evaluated by 2 independent clinicians. Visual inspection with a mirror was performed. Scores; 1: Restoration retained, no fractures, cracks or chipping 2: Small hairline crack 3: Two or more or larger hairline cracks and/or chipping (not affecting the marginal integrity or proximal contact) 4: Chipping fractures affect marginal quality and/or proximal contacts; bulk fractures with or without partial loss of (<1/2 of the restoration) 5: (Partial or complete) loss of the restoration | From Baseline to 12 Month | |
Primary | Marginal adaptation | Observers evaluated the restorations was performed using FDI criteria regarding marginal adaptation. Marginal adaptation was evaluated by 2 independent clinicians. Visual inspection with a mirror was performed. Scores; 1: Harmonious outline, no gaps, no discoloration 2: Small marginal chip fracture can be eliminated by polishing 3: Vertical/horizontal gap <250 µm, easily perceptible with a blunt explorer with a tip diameter of 250 µm. Several small marginal fractures cannot be modified without damage and are unlikely to cause longterm effects 4: Vertical/horizontal gap > 250 µm, may result in exposure of dentine or base 5: Restoration is loose but in situ | From Baseline to 12 Month | |
Primary | Proximal contact point and food impaction | Observers evaluated the restorations was performed using FDI criteria regarding proximal contact point and food impaction. Proximal contact point and food impaction was evaluated by 2 independent clinicians. Visual inspection with a dental floss and metal blades was performed. Scores; 1: Normal contact point (dental floss can be inserted but not 50 µm blade) 2: Slightly too strong but acceptable. Floss can only be passed with force 3: Slightly too weak (50 µm metal blade can pass easily whereas 100 µm [two blades] cannot) 4: 100 µm (two 50 µm metal blades) can easily pass and possible damage (food impaction) 5: Too weak and/ or clear damage (food impaction) and/or pain gingivitis | From Baseline to 12 Month | |
Primary | Radiographic examination | Observers evaluated the restorations was performed using FDI criteria regarding radiographic examination. Radiographic examination was evaluated by 2 independent clinicians.Scores; 1: No pathology, harmonious transition between restoration and tooth 2: Small visible but acceptable excess and/or a positive/ negative step or gap <150 µm 3: Gaps and/or positive/negative step <250 µm 4: Gaps and/or positive/negative step >250 µm and/or marked interradicular excess material 5: Gaps >500 µm and/ or secondary caries or apical pathology, tooth/ restoration fracture | From Baseline to 12 Month | |
Primary | Postoperative sensitivity and tooth vitality | Observers evaluated the restorations was performed using FDI criteria regarding postoperative sensitivity and tooth vitality. Postoperative sensitivity and tooth vitality was evaluated by 2 independent clinicians. Scores; 1: No hypersensitivity, normal vitality 2: Low hypersensitivity for a limited period of time, normal vitality 3: Premature/slightly more intense or delayed/weak hypersensitivity. No subjective complaints 4:Premature/very intense or extremely delayed/weak hypersensitivity with subjective complaints. Or negative sensitivity 5: Very intense, acute pulpitis or non vital tooth. Removal of restoration with or without immediate root canal treatment is required or the tooth must be extracted | From Baseline to 12 Month | |
Primary | Recurrence of initial pathology (secondary caries) | Observers evaluated the restorations was performed using FDI criteria regarding recurrence of initial pathology (secondary caries). Recurrence of initial pathology (secondary caries) was evaluated by 2 independent clinicians. Visual inspection with a mirror was performed. Scores; 1: No secondary or primary caries 2: Very small, localized demineralization area 3: Larger areas of demineralisation, preventive measures necessary (dentine not exposed) 4: Caries with cavitation 5: Deep secondary caries or exposed dentine that is not accessible for repair | From Baseline to 12 Month | |
Primary | Tooth cracks and fractures | Observers evaluated the restorations was performed using FDI criteria regarding tooth cracks and fractures. Tooth cracks and fractures was evaluated by 2 independent clinicians. Visual inspection with a mirror was performed. Scores; 1: Complete integrity 2: Minor marginal crack or a hairline crack which cannot be probed. The patient has no clinical symptoms 3: Enamel split or crack <250 µm. No adverse effects 4: Major enamel split (gap >250 µm or dentine/base exposed. Or crack>250 µm (explorer penetrates) 5: Cusp or tooth fracture | From Baseline to 12 Month | |
Primary | Localised reactions of soft tissue | Observers evaluated the restorations was performed using FDI criteria regarding localised reactions of soft tissue. Localised reactions of soft tissue in direct contact with the restoration was evaluated by 2 independent clinicians. Scores; 1: Healthy mucosa adjacent to restoration 2: Healthy after minor removal of mechanical irritations (sharp edges etc.) 3: Alteration of mucosa but no suspicion of causal relationship with filling material 4: Suspected mild allergic, lichenoid or toxicological reaction 5: Suspected severe allergic, lichenoid or toxicological reaction | From Baseline to 12 Month | |
Primary | Oral and somatic/ psychiatric symptoms | Observers evaluated the restorations was performed using FDI criteria regarding oral and somatic/ psychiatric symptoms. Oral and somatic/ psychiatric symptoms in direct contact with the restoration was evaluated by 2 independent clinicians. Scores; 1: No symptoms of adverse effects 2: Short-term minor transient symptoms 3: Minor oral and/or general symptoms of malaise 4: Persistent oral/general symptoms, recurrent symptoms 5: Acute/severe oral/general symptoms requires immediate replacement | From Baseline to 12 Month |
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